Effect of Renal Denervation on NO-mediated Sodium Excreti... | NCT01617551

Studies
Effect of Renal Denervation on NO-mediated Sodium Excretion and Plasma Levels of Vasoactive Hormones

NCT01617551

Sponsor

Regional Hospital Holstebro

Status

Unknown status

Last Update Posted

Mar 4, 2014Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Essential Hypertension

Interventions

NG-monomethyl-L-arginine (L-NMMA)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Mar 2014Estimated

Completion Date

Jun 2014Estimated

First Submitted Date

Jun 6, 2012

First Submission Date that Met QC Criteria

Jun 11, 2012

First Posted Date

Jun 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2014

Last Update Posted Date

Mar 4, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erling Bjerregaard Pedersen, Professor, MD, Dr.Sci., Regional Hospital HolstebroPrincipal Investigator

Lead Sponsor

Regional Hospital HolstebroOTHER

Collaborators

Name	Class
Aarhus University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Catheter based renal denervation (CRD) in humans represents a promising new treatment of resistant hypertension. CRD is currently investigated as a treatment option in patients with resistant hypertension defined as at least 3 antihypertensive drugs (including a diuretic) in a randomized, sham-controlled, multicenter trial in Denmark (ReSet). In ReSet, patients are randomized to either CRD or a sham procedure with 6 months follow up. The mechanisms by which CRD reduce blood pressure are only partly understood and the interaction between renal sympathetic nerves and nitric oxide (NO) has not been investigated in humans.

To Study the interaction between NO and renal sympathetic nerves, we designed the present substudy, where the effects of NO-inhibition on renal, hemodynamic and hormonal variables are studied before and after CRD.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Renal denervation	Experimental	Patient group randomized to renal denervation	Drug: NG-monomethyl-L-arginine (L-NMMA)
Sham	Sham Comparator	Patients randomized to sham procedure	Drug: NG-monomethyl-L-arginine (L-NMMA)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NG-monomethyl-L-arginine (L-NMMA)	Drug	Acute L-NMMA treatment (4,5 mg/kg loading dose followed by 3 mg/kg sustain infusion for 1 hour)	Renal denervation Sham

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fractional excretion of sodium after acute L-NMMA treatment		1 month before and after CRD

Secondary Outcomes

Measure	Description	Time Frame
Glomerular filtration rate (GFR) before and after L-NMMA treatment		1 month before and after CRD

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 30-70 years
Stable antihypertensive treatment for 1-month with at least 3 antihypertensive drugs including a diuretic
Day-time ambulatory blood pressure > 145/75 mmHg

Exclusion Criteria:

Non compliance
Pregnancy/no-anticonception in fertile women
Radiocontrast allergy
Malignancy
Congestive heart failure (EF < 50)
eGFR < 45
Unstable angina pectoris
Recent myocardial infarction or PCI (< 6 mdr)
Secondary hypertension
Renal artery stenosis or multiple renal arteries on CT
Claudication

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jesper N Bech, MD, Ph.D	Contact	+45 41627639		jnbech@dadlnet.dk

Overall Officials

Name	Affiliation	Role
Jesper N Bech, MD, Ph.D	Dept. of medical research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of medical research	Recruiting	Holstebro		7500	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D000075222	Essential Hypertension

Ancestor Terms

ID	Term
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019323	omega-N-Methylarginine

Ancestor Terms

ID	Term
D001120	Arginine
D024361	Amino Acids, Basic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided